Enliven Therapeutics has reported the latest positive results from the Phase I clinical trial showing promise of ELVN-001 for treating patients with chronic myeloid leukaemia (CML).
The trial enrolled CML patients irrespective of their T315I mutation status, who have not failed, not responded to or cannot receive existing treatments.
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Assessing the safety of ELVN-001 was the trial’s primary endpoint.
Evaluating the product’s pharmacokinetics, the rate and duration of major molecular response (MMR), BCR::ABL1 transcript levels, and complete haematologic response were assessed as secondary objectives.
The trial is structured as a dose escalation and expansion study to determine the optimal dose for further clinical research.
By the 24-week mark, a cumulative MMR rate of 44.4% was observed in 18 patients evaluable for response, mirroring the 12-week results previously shared in April.
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By GlobalDataELVN-001 also demonstrated a favourable safety profile without any dose reductions required and a median treatment duration of 20 weeks.
The therapy has not reached a maximum tolerated dose, and there have been no discontinuations due to treatment-emergent adverse events at doses ≥ 40mg, the company said.
Among the 16 patients assessed for efficacy at an earlier stage, all exhibited stable or improved responses between the 12 and 24-week evaluations.
In particular, ELVN-001 achieved a cumulative MMR rate of 41.7% in patients resistant to tyrosine kinase inhibitors (TKIs) and 40.0% in those previously treated with asciminib by the 24-week mark.
Notably, 23.1% of patients who were not in MMR at the start of the trial achieved MMR by week 24.
Enliven Therapeutics chief medical officer Helen Collins said: “We are excited by the continued advancement of the ELVN-001 Phase I trial, and we remain confident in ELVN-001’s potential to address the limitations of the available active-site TKIs.
“With more patients enrolled and longer follow-up, we continue to see anti-CML activity in a heavily pre-treated patient population that includes patients previously treated with asciminib. Additionally, ELVN-001’s safety profile remains consistent with its high selectivity, even with longer duration and more patients enrolled at higher dose levels.”
